INB03 for the Treatment of Pulmonary Complications From COVID-19

Sponsor

Inmune Bio, Inc. (Industry)

Overall Status

Terminated

CT.gov ID

NCT04370236

Collaborator

(none)

Enrollment

Locations

Arms

12.9

Actual Duration (Months)

8.8

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine whether XPro1595 can prevent the progression of respiratory complications in COVID19 patients.

Condition or Disease	Intervention/Treatment	Phase
COVID-19	Drug: INB03 Drug: Placebo	Phase 2/Phase 3

Detailed Description

The trial is a Phase 2, double-blind, randomized, placebo-controlled clinical trial of INB03 in participants with pulmonary complications due to COVID-19 infection.

Patients with COVID-19 infection and low blood oxygen levels with at least one high risk factor (see below) are eligible to participate in a 40-day study to determine whether INB03 can prevent the progression of pulmonary complications.

Eligible participants will be randomized (1:1) to receive either INB03 + standard of care (SOC) or Placebo + SOC. Participants randomized to INB03 + SOC will receive a 1mg/kg injection of INB03 after randomization. Patients that remain in the hospital 7 days after the first dose will receive a second dose. A final safety visit will occur on Day 70.

Study Design

Study Type:

Interventional

Actual Enrollment :

79 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Placebo + Standard of Care vs. INB03 + Standard of CarePlacebo + Standard of Care vs. INB03 + Standard of Care

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial of INB03 in the Treatment of Participants With Pulmonary Complications From Coronavirus Disease (COVID-19)

Actual Study Start Date :

Oct 21, 2020

Actual Primary Completion Date :

Oct 13, 2021

Actual Study Completion Date :

Nov 18, 2021

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo + Standard of Care Patients will receive placebo + standard medical care	Drug: Placebo Patients will receive up to two once per week subcutaneous injections of Placebo
Experimental: INB03 + Standard of Care Patients will receive INB03 + standard medical care	Drug: INB03 Patients will receive up to two once per week subcutaneous injections of 1mg/kg INB03 Other Names: DN-TNF, XPro1595, XENP345, Quellor

Arm

Intervention/Treatment

Placebo Comparator: Placebo + Standard of Care

Patients will receive placebo + standard medical care

Drug: Placebo

Patients will receive up to two once per week subcutaneous injections of Placebo

Experimental: INB03 + Standard of Care

Patients will receive INB03 + standard medical care

Drug: INB03

Patients will receive up to two once per week subcutaneous injections of 1mg/kg INB03

Other Names:

DN-TNF, XPro1595, XENP345, Quellor

Outcome Measures

Primary Outcome Measures

Proportion of participants with disease progression from randomization to 28 days post-randomization [28 days]
Disease progression is defined by the development of need for mechanical ventilation or death. Mechanical ventilation includes CPAP, BIPAP or mechanical ventilation requiring intubation.

Secondary Outcome Measures

Proportion of participants with all-cause mortality [28 days]
Proportion of participants who transfer to ICU level care by Day 28 (ICU level care is defined as a hospital setting where patient to nurse ratio is < 4); [28 days]
Proportion of participants with a new onset of neurologic disease (requiring medical intervention), including stroke by Day 28; [28 days]
Proportion of participants with evidence of new CHF or new MI requiring medical intervention by Day 28; [28 days]
Proportion of participants with a new onset embolus or thrombus by Day 28; [28 days]
Proportion of participants who develop a need for renal replacement therapy (defined as need for any type of dialysis including intermittent or continuous peritoneal or hemodialysis) by Day 28; [28 days]
Proportion of participants with an increase in the WHO Ordinal Scale of Clinical Improvement score at any time during the study; [28 days]
Length of hospital stay defined as the number of days in hospital from time of randomization to time of discharge or death, whichever occurs first; [28 days]
Change from baseline in inflammation markers over time. [28 days]

Other Outcome Measures

Incidence of adverse events and serious adverse events not due to underlying disease [28 days]
Incidence of abnormal findings in clinical safety laboratory parameters, vital signs, and ECGs. [28 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Have one or more of the following comorbidities:
Age ≥ 65 years;
Obesity (BMI ≥ 30);
Hypertension (on one or more drugs for treatment of hypertension);
Diabetes (on one or more drugs for Type I or Type II diabetes);
Cardiovascular disease (on one or more drugs for treatment of cardiovascular disease, other than aspirin);
History of congestive heart failure (CHF) or myocardial infarction (MI);
Black or African-American race (at least one parent identifies as Black or African-American);
Hispanic or Latino ethnicity.
Have a positive COVID-19 test in the last 28 days;
Have room air SaO2 < 96%, or SpO2 < 96% on room air at sea level, or PaO2/FiO2 < 300;
Have abnormal chest X-ray, MRI or CT scan consistent with pulmonary complications from COVID-19;
Provide written informed consent prior to any study related procedures being performed.

Exclusion Criteria:

Participants will be excluded from the study if 1 or more of the following criteria are applicable at Screening:

Age < 18 years;
Require immediate intubation due to advanced respiratory failure - including continuous positive airway pressure (CPAP) and bi-level positive airway pressure (BIPAP);
Require immediate admission to an Intensive Care Unit (ICU) for any reason;
On therapy with approved TNF inhibitor (eg: infliximab, etanercept, adalimumab, certolizumab pegol, golimumab, thalidomide, etc) in the last 6 months;
Being treated with dexamethasone (IV or PO) at a dose of >15mg per day or solumedrol or equivalent corticosteroid at a dose of >75mg per day;
Taking any medication known to be CCR5 receptor antagonist (eg: leronlimab, aplaviroc, vicriviroc or maraviroc) in the last 6 months;
Taking any medication known to inhibit the cytokine pathway (eg: anakinra, tocilizumab, siltuximab, etc) in the last 6 months;
Known to be pregnant;
Has known HIV, HCV or HBV infection;
Has known Mycobacterium tuberculosis infection or evidence of infection on chest X-ray;
Significant hepatic disease (ALT/AST> 4 times the ULN);
On therapy for cancer in the last 6 months;
On therapy for organ transplant in the last 6 months or on a waiting list for organ transplant, including patients on renal replacement therapy for any reason;
Known hypersensitivity to investigational product or its excipients;
Participating in an investigational drug or device trial;
Congestive heart failure (CHF) or myocardial infarction (MI) diagnosed in the last 2 months.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	NEA Baptist	Jonesboro	Arkansas	United States	72401
2	St. Bernard's	Jonesboro	Arkansas	United States	72401
3	Jewish Hospital	Louisville	Kentucky	United States	40202
4	Mississippi Baptist	Kosciusko	Mississippi	United States	39090
5	Baptist Memorial Hospital-DeSoto	Southard	Missouri	United States	38671
6	Richmond University Medical Center	Staten Island	New York	United States	10312
7	Baptist Clinical Research Institute	Memphis	Tennessee	United States	38120
8	Memorial Hermann	Houston	Texas	United States	77030
9	Memorial Hermann Southeast	Houston	Texas	United States	77089